Effective Treatment for Prescription Opioid Abuse
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- percentage of subjects abstinent from all opioids through the final day of detoxification
研究概览
简要总结
There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance.
详细描述
There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance. Aim 1) Conduct a randomized, three-parallel-groups clinical trial (Study 1) to determine a buprenorphine dose-tapering schedule that prevents the poor retention and relapse that undermine many opioid detoxification regimens. Aim 2) Conduct a randomized, three-parallel-groups clinical trial (Study 2) to determine a duration of naltrexone therapy that sustains opioid abstinence following the buprenorphine detoxification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For inclusion in the proposed studies, subjects must be > 18 years old and in good health. Subjects must meet DSM-IV criteria for opioid dependence and FDA qualification criteria for buprenorphine treatment, including a history of opioid dependence and significant current opioid use (i.e., opioid-positive urines). Subjects must also be seeking or willing to accept opioid detoxification.
排除标准
- •Because the primary focus of the proposed research is to develop an efficacious intervention for prescription opioid abuse that employs a buprenorphine taper and subsequent naltrexone maintenance, individuals who require ongoing opioid therapy for pain or other chronic medical conditions will be excluded from participating.
- •Individuals with evidence of an active psychiatric disorder that may interfere with consent or participation in the research (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., cardiovascular disease) or who are pregnant or nursing will be excluded from participation.
研究组 & 干预措施
4-week buprenorphine taper
4-week buprenorphine taper + behavioral therapy + urine toxicology
干预措施: Behavioral therapy (Behavioral)
1-week buprenorphine taper
1-week buprenorphine taper + behavioral therapy + urine toxicology
干预措施: buprenorphine taper followed by naltrexone maintenance (Drug)
1-week buprenorphine taper
1-week buprenorphine taper + behavioral therapy + urine toxicology
干预措施: Behavioral therapy (Behavioral)
2-week buprenorphine taper
2-week buprenorphine taper + behavioral therapy + urine toxicology
干预措施: buprenorphine taper followed by naltrexone maintenance (Drug)
2-week buprenorphine taper
2-week buprenorphine taper + behavioral therapy + urine toxicology
干预措施: Behavioral therapy (Behavioral)
4-week buprenorphine taper
4-week buprenorphine taper + behavioral therapy + urine toxicology
干预措施: buprenorphine taper followed by naltrexone maintenance (Drug)
结局指标
主要结局
percentage of subjects abstinent from all opioids through the final day of detoxification
时间窗: up to 12-week trial
次要结局
- percentage of subjects retained in treatment through the final day of detoxification(up to 12-week trial)